Investigation of Lipedema, Lymphedema and Vascular Malformations by Multispectral Optoacoustic Tomography (MSOT)

NCT06399367 | Enrolling By Invitation FDA Device

• 1 other identifier: 16/10/19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to analyze the fatty tissue architecture of the subcutaneous tissue in patients from the plastic surgery department. Plastic surgery patients show a wide variety of subcutaneous fatty tissue structures during clinical examination. These include patients with edema of the extremities such as lipedema or lymphedema. Fatty tissue architecture plays a major role in our everyday lives, as wound healing and scar formation, for example, are influenced by the blood flow to the overlying skin. The fatty tissue architecture, especially in the subcutaneous fatty tissue, also plays a major role in our appearance. An analysis of the architecture can potentially provide information about the genesis of different skin fold formations. The aim of this study is to quantitatively describe structural differences in adipose tissue architecture. Adipose tissue architecture is still a largely unexplored area because imaging has not been possible to date. MSOT imaging is similar to conventional sonography in that a transducer is placed on the skin and energy is supplied to the tissue by pulsed laser light instead of sound. On a macroscopic level, this leads to a constant change of minimal oscillations of individual tissue components. The resulting sound waves can then be detected by the same transducer. Previous studies have shown that the quantitative determination of hemoglobin can be used to obtain information on blood circulation and inflammatory activity. In the extended spectrum, in contrast, not only hemoglobin and its oxygenation stages but also other biomarkers such as collagens and lipids can be detected. This is very useful for imaging of fat, lymphatics and normal and abnormal blood vessels in vascular malformations. This process was largely researched by the working group of Prof. Ntziachristos (Helmholtz Center Munich and Technical University of Munich) and Prof. Razansky (Eidgenösische Technische Hochschule Zurich) and is being further developed into a clinically applicable technology and sold commercially by the company iThera. As a first series of demonstrative clinical studies following rigorous technical development, MSOT will serve as a key tool for research partners in the investigation of several diseases that remain poorly-understood and have limited treatment options. These parallel studies will focus on lipedema and lymphedema as well as vascular malformations - three distinct disease groups with similarly unmet clinical needs for appropriate imaging modalities and high potential of translation to further major disease areas. By focusing on two unrelated diseases, this project will show the wide-reaching application of this innovative imaging approach. Following successful proof-of-principle validation in a clinical research environment, full exploitation and dissemination of the results will strive to deliver MSOT to the greater scientific community. The main objectives are to confirm/validate the spectral profile of fat and vasculature on MSOT in lipedema patients, to establish the spectral profile of vascular malformations based on MSOT for adults and children and to establish the spectral profile and imaging of lymphatic vessels. With a detailed analysis of the architecture, our understanding of the physiology and pathology of the skin may be enhanced.

Conditions

Lipedema; Lymphedema; Vascular Malformations

Outcome Measures

Primary Outcomes (1)

• Visualization of subcutaneous fatty tissue

  The aim is to display and analyze the architecture of the subcutaneous fatty tissue in plastic surgery patients using MSOT

  After inclusion of the subject the architecture of the subcutaneous fatty is visualized one time at baseline. There will be only one examination of each patient.

Study Arms (2)

Lipedema/MSOT Cohort

MSOT measurements are carried out on 50 subjects with changes in the subcutaneous fatty tissue (e.g. lipedema). In these studies, adult patients (\>18 years, \<80 years) are included with the indicators mentioned below, after risk information and voluntary consent. 1. Typical tenderness in the calf, back of the knee or lateral thigh 2. Tendency to hematoma in areas affected by edema 3. Typical appearance of fatty tissue distribution with dent formation, asymmetry in lateral comparison and increased circumference 4. Tendency to edema throughout the day with typical feeling of pressure/pain 5. Unsuccessful conservative therapy attempts and weight loss attempts

Diagnostic Test: MSOT

Non-Lipedem/MSOT Cohort

MSOT measurements are carried out on 50 subjects with clinically healthy subcutaneous fatty tissue. In these studies, adult patients (\>18 years, \<80 years) are included after exclusion of the indicators mentioned below, after risk information and voluntary consent. 1. Typical tenderness in the calf, back of the knee or lateral thigh 2. Tendency to hematoma in areas affected by edema 3. Typical appearance of fatty tissue distribution with dent formation, asymmetry in lateral comparison and increased circumference 4. Tendency to edema throughout the day with typical feeling of pressure/pain 5. Unsuccessful conservative therapy attempts and weight loss attempts.

Diagnostic Test: MSOT

Interventions

MSOT DIAGNOSTIC_TEST

The MSOT system used consists of a laser in the visible near-infrared and far-infrared wavelength range (660nm-1300nm) and an ultrasonic sensor connected to a computer. Using optical components, the area to be measured is illuminated with ultra-short light pulses of selectable wavelength. The light is absorbed to varying degrees inside the object - depending on the properties of the tissue. The absorption of light leads to local microscopic volume fluctuations and thereby emits pressure waves in the ultrasonic range (photoacoustic effect). MSOT enables non-invasive, non-ionizing 2D imaging with high spatial resolution (80 μm), which enables specific visualization of endogenous tissue pigments such as collagen fibers, fat, melanin, oxyhemoglobin and deoxyhemoglobin.

Lipedema/MSOT Cohort; Non-Lipedem/MSOT Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects for this study are recruited from the trauma surgery, orthopedics and plastic surgery clinic and polyclinic. In particular, patients are recruited from the special plastic surgery consultation hours.

You may qualify if:

• Typical tenderness in the calf, back of the knee or lateral thigh
• Tendency to hematoma in areas affected by edema
• Typical inspection disorder of fatty tissue distribution with dent formation, asymmetry in lateral comparison and increased circumference
• Tendency to edema throughout the day with typical feeling of pressure/pain
• Unsuccessful conservative therapy attempts and weight loss attempts.

You may not qualify if:

• Age \<18 or \>80
• pregnancy and breastfeeding
• Lack of voluntary consent

Sponsors & Collaborators

• University Hospital Goettingen: lead

Study Sites (1)

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

MeSH Terms

Conditions

Lipedema; Lymphedema; Vascular Malformations

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laura Hansen, Resident Physician, Department of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: May 3, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

DE (1)